Actively Recruiting
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Led by Children's Hospital of Philadelphia · Updated on 2025-07-28
60
Participants Needed
3
Research Sites
102 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature who have been diagnosed with bronchopulmonary dysplasia. The main questions this trial aims to answer are: Does transpyloric as compared to gastric tube feeding result in differences in the amount of experienced hypoxemia (low oxygen level in the blood) or serious adverse events? Does transpyloric as compared to gastric tube feeding reduce the frequency and severity of gastroesophageal reflux (GER) measured using 24 hour esophageal pH-multichannel intraluminal impedance (pH-MII) monitoring? Participants will: Undergo pre-trial 24 hour pH-MII monitoring to determine baseline severity of GER. Be randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks. Undergo repeat pH-MII at the end of the 2 week trial to assess for change in GER. Undergo continuous pulse oximetry to record level of hypoxemia during the 2 week trial. Undergo saliva and airway (if supported by a breathing tube) fluid collection to measure biomarkers of GER. Be monitored clinically for possible adverse events.
CONDITIONS
Official Title
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born before 32 weeks' gestation
- Current postmenstrual age between 36 and 65 weeks
- Grade 2-3 bronchopulmonary dysplasia or grade 1 with need for prolonged airway support and full tube feedings
- Receiving positive airway pressure support at enrollment
- Receiving full gastric tube feedings (at least 100 mL/kg/day) at enrollment
- Parental consent to participate
You will not qualify if you...
- Received transpyloric feeding within 7 days before enrollment
- Used gastric acid suppression, GI promotility drugs, or caffeine within 7 days before enrollment
- History of gastrostomy tube, gastric fundoplication, or bowel resection causing short gut making transpyloric feeding unsafe
- Planned weaning off airway pressure or extubation during the 2-week trial
- Known intolerance to transpyloric feeding
- Persistent greater than 20% endotracheal tube leak (for intubated subjects)
- Currently receiving an investigational therapy in another clinical trial
- Severe congenital or genetic abnormalities affecting gastrointestinal or cardiopulmonary function
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Stanford University
Palo Alto, California, United States, 94304
Not Yet Recruiting
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Not Yet Recruiting
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
E
Erik A Jensen, MD, MSCE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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